What are Good Manufacturing Practices? They are a set of practices that are required to comply with regulations and industry standards that insure that your products are effective as claimed and are pure and defect free. GMPs minimize the risks associated with processing and manufacturing products. Every country to include the US with the FDA has their own set of governing GMP regulations. Some of these regulations are harmonized with others while some are not. They are not guidelines…they have the weight of law. They essentially dictate how work and the workers executing that work must conduct their work activities. GMPs touch upon virtually every aspect of work life and the processes that are performed as integral components of that work.
GMPs govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished products intended for human use.
The purpose of these regulations? It is very simple - to ensure that medical/medicinal are safe and effective. Achieving this safety and effectiveness requirement however is not so simple. It is achieved by implementing what is known as a Quality System consisting of many regulatory requirements as specified in the governing regulations that must be:
- Documented in the form of Standard Operating Procedures and Work Instructions
- Integrated into the fabric of how the business executes the activities required to place a medical/medicinal product into the marketplace
- Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
- Be provable when externally audited to verify its effectiveness and compliance with the regulation
Why Should You Attend
Why should you attend this webinar and why is it important to you? If you work within regulated medical product industries, almost everything that you do every day is somehow touched by this regulation. Ignorance of the sections of this regulation is no excuse for non-compliance. It takes a complete thorough understanding of the regulation to ensure your compliance to it. This webinar will provide that level of understanding and some basic guidance to assure compliance.
Agenda
- What are the regulations governing Good Manufacturing Practices?
- Quality Management
- Personnel
- Premises and equipment
- Documentation
- Production
- Quality Assurance
- Materials management
- Production and in-process controls
- Packaging and labeling
- Storage and distribution
- Laboratory controls
- Validation
- Change control
- Rejection and re-use of material
- Complaints and recalls
- Supplier controls
Speakers
Charles H. Paul,
President ,
C. H. Paul Consulting, Inc.Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
He has dedicated his entire professional career explaining the benefits of performance-based training
Who Should Attend
Anyone involved in the production of GMP regulated medicinal products - pharmaceuticals, medical devices, and biologics
